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Completed

NCT Number: NCT05040685

Axillary Reverse Mapping in Breast Cancer

The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.

In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.

HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who will undergo ALND in the treatment of breast cancer:

  • cT4a, cT4c and cT4d.
  • cT4b with extensive involvement of the skin.
  • cN0 with SLNB positive (pN+) that need to associate ALND:
  • cT3-T4b.
  • >2 lymph node macrometastasis if cTis, cT1 and cT2.
  • Patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy.
  • cN1:
  • If primary surgery treatment.
  • After neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or SLNB positive (ypN+).
  • cN2:
  • If primary surgery treatment.
  • After neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or HER2 overexpressed tumours.
  • cN3.

Exclusion criteria

  • Patients with previous axillary surgery (except sentinel node biopsy)
  • Patients who did previous axillary radiotherapy treatment.
  • Patients who do not wish to participate in the study.

Treatment and study plan

Axillary mapping reverse

Procedure

At the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study.

Primary outcomes

  1. Rate of patients who it is possible preserve ARM nodes

    Time frame: 1 year

    Determinate the percentage of patients who is possible preserve the ARM node during ALND

Secondary outcomes

  1. Rate of metastatic ARM

    Time frame: 1 year

    Determinate the percentage of metastatic ARM nodes.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery

Acronym: ARM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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